East Sydney Doctors | Darlinghurst, Australia
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About
The purpose of Part A of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccines to control vaccine.
The purpose of Part B of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccine under three different storage conditions.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Is at least 18 years old and has achieved legal age according to local regulations in each participating country.
Must provide documented informed consent prior to any study procedures being performed.
Can and will comply with the requirements of the protocol, in the opinion of the investigator.
Is healthy or medically stable as determined by the investigator's judgment based on medical history, vital sign measurements, and physical examination findings. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
Prior receipt of an mRNA COVID-19 vaccine. This may be from a completed primary vaccination series or booster dose(s) of an approved or authorized mRNA COVID-19 vaccine. The last vaccination must be an mRNA COVID-19 vaccination received at least 3 months prior to randomization.
If the participant is a woman of childbearing potential, the participant may be enrolled in the study, if they:
Female participants of non-childbearing potential may be enrolled in the study. Nonchildbearing potential is defined as current salpingectomy, hysterectomy, ovariectomy, or postmenopausal.
Participants are excluded from the study if any of the following criteria apply:
Primary purpose
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Interventional model
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675 participants in 8 patient groups
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Data sourced from clinicaltrials.gov
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